FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. §

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Animal Testing Biosimilars Cell Based Assays FDA 64

Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

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Animal Testing Regulations Production Research 40

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. These rats, known as AA or P-lines, serve as animal models of alcoholism, exhibiting high alcohol-seeking behavior, withdrawal symptoms, and a predisposition to co-abuse ethanol and nicotine.

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Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 27,28 Since the advent of hiPSC technology almost two decades ago enormous progress has been made in many areas of research. Cell Stem Cell. 2017 Jul 6;21(1):14–7.

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Drugs FDA Disease Animal Testing 111

Agency IQ

JANUARY 19, 2024

This also has clear potential to reduce animal testing, another key commitment made by the Commission. It obligates industry and the laboratories and testing facilities they employ to submit a notification to a database hosted by the CDPC when chemical safety assessments are commissioned.

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Packaging Regulations Laboratories Animal Testing 40

PLOS: DNA Science

APRIL 4, 2024

The earliest patent I found was issued in late 2009, for “Products and Methods for Reducing Malodor from the Pudendum.” ” But, tellingly, “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” What’s the stink test?

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Disease Production Testimonials FDA 92